• 1. Premarket Approval: 前许可 | 上市前许可 | 上市前审批 | 一般控制
• 2. PREMARKET APPROVAL OF MEDICAL DEVICES: 医疗器械的上市前批准
• 3. PMA Premarket Approval: 售前许可

• 1.These requirements include establishment registration, medical device listing, quality system, medical device reporting, premarket approval or clearance, labeling and U. s. agent requirements.
  这些规定包括工厂的注册，医疗设备清单，质量系统，医疗设备报告，售前批准或者认可，商标及美国代理的要求。
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